Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

XEROSTOMIA Clinical Trial

Official title:

Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren`s Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066896
• Other study ID #: LLLXS
• Status: Recruiting
• Phase: Phase 3
• First received: August 15, 2013
• Last updated: February 1, 2016
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Federal University of São Paulo
• Contact: Tania A Fidelix, investigator
• Phone: 55 11 991346992
• Email: fidelixtania[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

Description:

The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands.

The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays.

Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with primary Sjogren Syndrome according criteria american european 2002.

• Salivary flux non stimulated < 0,1 ml/min.

Exclusion Criteria:

• hepatitis B and/or C

• radiotherapy in the glandular area (previous)

• other connective diseases

• thyroidopathy non compensated

• GVHD graft-versus-host disease

• HIV

• Sarcoidosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• PRIMARY SJOGREN SYNDROME
• SICCA SYNDROME
• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Device:
• Lasertherapy
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
• Sham Lasertherapy
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).

Locations

Country	Name	City	State
Brazil	Tania S A Fidelix	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The xerostomia inventory	The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.	up to sixth week (changes from baseline)	No
Secondary	Salivary biomarker analysis	Saliva samples will be submitted to chemical analysis for sodium, chloro, Beta 2 microglobulin	up to sixth week (changes from baseline)	No
Secondary	Salivary flux measurement	The salivary flux will be measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room, spilled saliva in a collector tube graduated in mm.	up to sixth week (changes from baseline)	No